A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults

The Ohio State University

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Family dyad diabetes intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05905575

2023 H0010

Details and patient eligibility

About

A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).

Full description

Eligible participants and their family members will be randomly assigned to either the intervention and control group. Patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. All participants will be assessed at baseline, post-intervention and six months after intervention.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Individual with type 2 diabetes:

• Self-identification as African American;
• 40 years or older
• Type 2 diabetes diagnosis for at least six months;
• A1c > 7.0% at time of enrollment;
• Being able to speak and read English;
• Being able to walk;
• Having an adult family member/close friend willing to co-participate in the study.

Family members:

• Adults (18 years or older, with or without T2D);
• Residing in the same household as the T2D participants;
• Being a spouse, adult child or sibling; or close friend
• Being able to walk;
• Being able to speak and read English.

Exclusion criteria

Individual with T2D and family members:

• Being pregnant or have an advanced or terminal condition;
• Being cognitively impaired or unable to provide informed consent;
• Lack conclusive evidence of T2D for patients with T2D.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Intervention

Experimental group

Description:

Patient-family member dyads in the family dyad intervention arm will receive 1) 10 sessions (8 weekly and 2 biweekly) over 12 weeks of family-dyad-focused, virtual group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.

Treatment:

Behavioral: Family dyad diabetes intervention

Control

No Intervention group

Description:

All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.